This policy version was replaced May 2, 2022. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

Intra-articular injection of hyaluronan (viscosupplementation) has been proposed as a means of restoring the normal viscoelasticity of the synovial fluid in patients with osteoarthritis. Hyaluronan, also known as hyaluronate or hyaluronic acid, is a naturally occurring macromolecule that is a major component of synovial fluid and is thought to contribute to its viscoelastic properties.

Several preparations of intra-articular hyaluronan have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics. The FDA has not approved intra-articular hyaluronan for joints other than the knee. 

NOTE: This policy applies to commercial health plan members and Minnesota Health Care Program subscribers to Families and Children, MinnesotaCare, and Minnesota Senior Care Plus.

I.    Initial Review for Synvisc®, Synvisc-One®, and Euflexxa®

Intra-articular hyaluronan injections (Synvisc®, Synvisc-One®, and Euflexxa®) may be considered MEDICALLY NECESSARY AND APPROPRIATE for the treatment of painful osteoarthritis of the knee in patients who meet ALL of the following criteria:

• There is documentation of a diagnosis of osteoarthritis of the knee supported by radiologic evidence including one or more of the following:
  • Joint space narrowing,
  • Subchondral sclerosis,
  • Osteophytes and sub-chondral cysts; AND
• There is documentation that pain due to osteoarthritis of the knee interferes with functional activities (e.g., walking, prolonged standing); AND
• Pain has persisted despite use of BOTH of the following within the previous 6 months:
  • Medical management with acetaminophen, nonsteroidal anti-inflammatory agents (NSAIDS) or other analgesic medications for a minimum of 3 months unless there is a contraindication to use; AND
  • Physical therapy: 4 week course; AND
• There is no evidence of other joint disease (e.g., rheumatoid or psoriatic arthritis); AND
• For commercial health plan members only, step therapy supplement criteria may apply for select conditions (see policy II-242: Step Therapy Supplement).
  

II.   Initial Review for All Other Intra-Articular Hyaluronan Injections

All other intra-articular hyaluronan injections may be considered MEDICALLY NECESSARY AND APPROPRIATE for the treatment of painful osteoarthritis of the knee when ALL of the following criteria are met:

• Initial review criteria outlined in section I are met; AND
• One of the following:
  • Previously tried and failed Synvisc®/Synvisc-One® and Euflexxa®; or
  • Documented intolerance, FDA labeled contraindication, or hypersensitivity to Synvisc®/ Synvisc-One® and Euflexxa®;
• AND
• For commercial health plan members only, step therapy supplement criteria may apply for select conditions (see policy II-242: Step Therapy Supplement).

III.  Renewal Review for All Intra-Articular Hyaluronan Injections

A repeat-course of intra-articular hyaluronan may beconsidered MEDICALLY NECESSARY AND APPROPRIATE when ALL of the following criteria have been met:

• The individual met all of the criteria for an initial course of treatment; AND
• At least 6 months have passed since the conclusion of the prior treatment course; AND
• Significant pain relief was achieved with the prior course of injections.

IV.   Use of ultrasound guidance for intra-articular hyaluronan injection is considered EXPERIMENTAL/INVESTIGATIVE due to the lack of clinical evidence demonstrating an impact on improved health outcomes.

V.    Injection of corticosteroids concomitantly with hyaluronan is considered EXPERIMENTAL/INVESTIGATIVE due to the lack of clinical evidence demonstrating an impact on improved health outcomes.

VI.   The use of intra-articular hyaluronan injections for the following indications is considered EXPERIMENTAL/INVESTIGATIVE due to the lack of clinical evidence demonstrating an impact on improved health outcomes.

• Injection into joints other than the knee including but not limited to the foot, ankle, hip, shoulder, elbow and hand.
• Injection for chondromalacia patella (patellofemoral syndrome) or osteoarthritis dissecans.

Documentation Submission:

Documentation supporting the medical necessity criteria described in the policy must be included in the prior authorization, when prior authorization is required. In addition, the following documentation must also be submitted:

• Written report describing findings from diagnostic imaging studies of the knee; AND
• Clinical notes describing:
  1. Diagnosis and clinical features of the diagnosis; AND
  2. Pain due to osteoarthritis of the knee and functional limitations related to knee pain; AND
  3. Medical management with acetaminophen, nonsteroidal anti-inflammatory agents (NSAIDS), or other analgesic medications for a minimum of 3 months within the previous 6 months, including response to the medications; AND
  4. Physical therapy for a minimum of 4 weeks within the previous 6 months, including response to physical therapy.
• For a repeat course of intra-articular hyaluronan, clinical notes describing:
  1. Individual met all of the criteria for an initial course of treatment; AND
  2. Conclusion date of the prior treatment course; AND
  3. Level of pain relief achieved with the prior course of injections.
• For commercial health plan members only, when step therapy requirements apply for the requested indication, documentation for one or more of the step therapy supplement criteria MUST be provided (see policy II-242).